Clinical Research Project Lead
Posted on Feb 5, 2019 by HumanEdge
Primary responsibilities will include:
Design, execution and report studies - Define the scope of work, selection, management and oversight of CROs, trial sites and vendors.
Lead the development, review, and approval of all study documents.
Manage and report program updates and performance metrics to senior management.
Our client is a global biopharmaceutical leader advancing life-changing therapies and medical breakthroughs where none currently exist.
Direct the creation and execution of clinical trial activities in accordance with internal SOPs, ICH Guidelines, and Good Clinical Practice (GCP). Ensure compliance of clinical trials with local regulatory requirements; overall data quality and integrity; and human subject protection.
Lead cross functional clinical study team to achieve study milestones. Interact with internal and external groups to achieve study milestones. Communicate clinical studies performance data to other members of the management and scientific team.
Determine study requirements, define specifications, and initiate and lead the selection of third party vendors. Manage CRO relationship to ensure the appropriate scope of work, oversight and training of clinical investigators and site staff in order to achieve study milestones within agreed upon timelines, budget and quality. Manage clinical study budgets within agreed variance.
Key contributor to the development, review and approval of study documents including but not limited to protocol, ICF, statistical analysis plan, and clinical study report. Prepare and maintain required study and regulatory documentation, e.g., reports for Competent Authority submissions, informed consent, monitoring plan, Pharmacy Manual, investigator contracts and budgets.
May provide input into the clinical development strategy including but not limited to operational feasibility, budget and timeline estimates. May participate in and/or lead department initiatives. Document continuous improvement process and sharing of best practices.
Minimum Bachelor's degree in a life science or healthcare discipline, an advanced degree is desirable.
PMP certification desirable
A seasoned clinical operations professional 5+ years' of experience in clinical research and a competency level sufficient to act as a subject matter expert.
Skilled in team development with demonstrated technical leadership skills with cross-functional clinical expertise for effective problem solving and successful execution of the clinical plan for a study that includes site management & monitoring, drug supply, data management, medical monitoring, biostatistics, medical writing, drug safety, and regulatory affairs.
Excellent verbal and written communication skills. Ability to communicate effectively and relevantly to customers and colleagues (internal and external).
Management and oversight of CROs plus a track record of ensuring GCP compliance and risk management of clinical studies is expected.
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